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Table 2 IDMC recommendations from first four meetings

From: When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children

First Meeting (25 February 2009):
Requested details of adverse event reporting and listings of all individual events by patient identification
Second Meeting (18 June 2009):
Requested information on children screened for the trial but not enrolled
Requested the number and quantity of additional fluids (other than boluses) given to all children
Asked the study teams to make extra effort to ensure that all children attend for neurological examination at 28 days
Third meeting (12 October 2009):
Endorsed the review procedure for SAE proposed, and stressed the importance of blinded review by the ERC
Accepted co-enrollment of children into other studies
Noted planned sub-studies
Fourth meeting (26 January 2010, third interim analysis):
Observed improvement in attendance for neurological follow up at 28 days
Referred the request by a local IRB for representation on the IDMC to the TSC
Requested more detailed information on all fluids received in each arm by time from randomization
Agreed with the proposed plan of analysis